The goal of this clinical research study is to find the highest tolerable dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.

Bevacizumab 5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle. Temsirolimus 5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle. First tumor biopsy during screening visit and Second at the end of Cycle 1. DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1.

Drug: Bevacizumab

5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle

Other Names:

Avastin

Anti-VEGF monoclonal antibody

rhuMAb-VEGF

Drug: Temsirolimus

5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle

Other Names:

Torisel

CCI-779

Procedure: Additional Blood Drawn

2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1.

Procedure: Biopsy

First tumor biopsy during screening visit and Second at the end of Cycle 1

Procedure: DCE-MRI Scan

DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1

Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.

Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.

Ability to understand and the willingness to sign a written informed consent document

Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.

Exclusion Criteria:

Patients with hemoptysis within 28 days prior to entering the study.

Patients with clinically significant unexplained bleeding within 28 days prior to entering the study

History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.

History of hypersensitivity to Temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation

Patients that are taking CYP3A4 inducers and/or inhibitors. Please see section 3.2 in the protocol for details. If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610493